BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERIC MEDICAL LLC

    MDR report key: 24870247 · Received April 14, 2026

    Report

    Report Number
    3003560965-2026-00009
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    KST
    UDI-DI
    10885380182945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    1. REVIEW OF PRODUCTION PROCESS: THE BATCH RECORDS OF THE PRODUCTION PROCESS AND THE FINISHED PRODUCT RELEASE INSPECTION RECORDS OF THE ABOVE BATCH WERE TRACED. NO CHANGES WERE MADE TO RAW MATERIALS OR PRODUCTION PROCESSES. NO ABNORMALITIES WERE FOUND DURING EITHER THE PRODUCTION PROCESS OR FINISHED PRODUCT INSPECTION PROCESS, AND THE FINISHED PRODUCT PASSED THE RELEASE INSPECTION. OUR COMPANY HAS CONFIRMED THE HARDNESS REQUIREMENTS FOR THE RUBBER SLEEVE WITH THE SUPPLIER AND REQUIRES THE SUPPLIER TO STRICTLY CONTROL THE HARDNESS OF THE RUBBER SLEEVE. UPON ARRIVAL, OUR COMPANY TESTS THE TENSILE PROPERTIES AND RESILIENCE OF THE RUBBER SLEEVE (RESILIENCE TESTING IS PERFORMED USING KDL COLLECTION TUBES), SO AS TO ENSURE THAT THE BLOOD COLLECTION TUBE WILL NOT BE EJECTED WHEN THE RUBBER SLEEVE IS USED WITH THE BLOOD COLLECTION ADAPTER. 2. RETAINED SAMPLE TESTING: FIVE RETAINED SAMPLES OF THE BLOOD COLLECTION ADAPTER WITH BATCH NO.: 250728 AND SPECIFICATION: 20G*19MM WERE SELECTED FOR TESTING: VISUAL INSPECTION: THE SURFACE OF THE RUBBER SLEEVE OF THE BLOOD COLLECTION ADAPTER WAS SMOOTH, AND ALL COMPONENTS WERE INTACT. SIMULATED CLINICAL BLOOD COLLECTION TESTS WERE CONDUCTED, AND NO TUBE EJECTION WAS OBSERVED IN ANY SAMPLE. 3. ROOT CAUSE ANALYSIS: NO ABNORMALITIES WERE IDENTIFIED BASED ON THE ABOVE INVESTIGATION. IN CLINICAL USE, THE BLOOD COLLECTION NEEDLE MUST BE USED WITH A BLOOD COLLECTION TUBE TO COMPLETE BLOOD COLLECTION. TUBE EJECTION INVOLVING THE BLOOD COLLECTION NEEDLE MAY BE ATTRIBUTED TO MULTIPLE FACTORS, SUCH AS THE RESILIENCE AND HARDNESS OF THE RUBBER PLUG OF THE BLOOD COLLECTION NEEDLE; THE HARDNESS, THICKNESS AND CLAMPING FORCE OF THE RUBBER PLUG ON THE BLOOD COLLECTION TUBE; THE POSITION WHERE THE PUNCTURE NEEDLE IS INSERTED INTO THE RUBBER SLEEVE OF THE COLLECTION TUBE, ETC.

    Description of Event or Problem · 0

    WHEN USING TO DRAW LABS FROM IV, THE ADAPTER IS CAUSING BLOOD COLLECTION TUBES TO POP OFF. THE TUBES FEEL PRESSURIZED AND BLOOD SPRAYS ON THE PATIENT. THIS IS FOR MULTIPLE DIFFERENT BLOOD TUBES MAINLY WITHOUT GEL/MEDIUM. MULTIPLE TUBES WERE USED BEFORE THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940574 MAVERIC MEDICAL LLC BLOOD COLLECTION ADAPTER KST ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 20G*19MM 250728 10885380182945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown